DCT
2:22-cv-05860
Azurity Pharma Inc v. Novitium Pharma LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Azurity Pharmaceuticals, Inc. (Delaware)
- Defendant: Novitium Pharma, LLC (Delaware)
- Plaintiff’s Counsel: Saiber LLC; Wilson Sonsini Goodrich & Rosati
- Case Identification: 2:22-cv-05860, D.N.J., 10/03/2022
- Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendant Novitium Pharma, LLC's principal place of business being located in the state.
- Core Dispute: Plaintiff seeks a declaratory judgment that Defendant's imminent manufacture and sale of a generic enalapril oral solution will infringe two patents covering stable liquid formulations of the drug.
- Technical Context: The technology concerns ready-to-use liquid formulations of enalapril, an ACE inhibitor used to treat hypertension, designed to improve stability and dosing accuracy for patient populations such as children and the elderly who may have difficulty with solid tablets.
- Key Procedural History: The complaint notes that the patents-in-suit are listed in the FDA's "Orange Book" for Plaintiff's Epaned® product. It also references prior, ongoing patent litigation against Bionpharma Inc. (the ANDA holder for the accused product) and CoreRx, Inc. (the previous manufacturer) involving the same patents and the same generic drug formulation, which may be relevant to allegations of knowledge and intent.
Case Timeline
| Date | Event |
|---|---|
| 2016-03-18 | Priority Date for ’023 and ’405 Patents |
| 2021-06-22 | U.S. Patent No. 11,040,023 Issues |
| 2021-06-22 | Plaintiff sues Bionpharma Inc. for infringement of the ’023 Patent |
| 2021-08-10 | FDA approves ANDA No. 212408 for generic enalapril formulation |
| 2021-10-12 | U.S. Patent No. 11,141,405 Issues |
| 2021-10-15 | Plaintiff sues Bionpharma Inc. for infringement of the ’405 Patent |
| 2022-04-01 | Plaintiff sues prior manufacturer CoreRx, Inc. for infringement |
| 2022-06-01 | Defendant Novitium Pharma is listed as manufacturer of the ANDA product (approx. date) |
| 2022-10-03 | Complaint for Declaratory Judgment Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,040,023 - “Enalapril Formulations”
The Invention Explained
- Problem Addressed: The patent’s background section describes difficulties associated with administering enalapril, a hypertension drug, to patient populations like children and the elderly who struggle to swallow solid tablets. It notes that alternatives, such as crushing tablets or using powder reconstitutions, can lead to inaccurate dosing, instability, and potential contamination (’023 Patent, col. 5:31-61).
- The Patented Solution: The invention is a stable, ready-to-use oral liquid formulation of enalapril that avoids the need for reconstitution or tablet crushing (’023 Patent, col. 5:21-24). The claimed solution achieves stability through a specific combination of ingredients, including a sweetener, a preservative, and water, maintained at a pH of less than 3.5 to minimize the formation of known degradation products (’023 Patent, col. 2:32-38; col. 13:38-46).
- Technical Importance: The invention provides a commercially stable, liquid dosage form of a widely used cardiovascular drug, which is particularly suited for pediatric and geriatric patients for whom accurate dosing and ease of administration are critical (’023 Patent, col. 5:41-49).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶38).
- The essential elements of independent claim 1 are:
- A stable oral liquid formulation, consisting essentially of:
- (i) about 0.6 to about 1.2 mg/ml enalapril or a pharmaceutically acceptable salt or solvate thereof;
- (ii) a sweetener;
- (iii) a preservative, comprising sodium benzoate, a paraben, or a mixture of parabens;
- (iv) water; and
- (v) optionally a flavoring agent;
- wherein the formulation meets specific stability criteria for at least 12 months at 5±3° C, retaining at least 95% of the initial enalapril amount with 5% or less total impurity.
- The complaint does not explicitly reserve the right to assert dependent claims but refers to infringement of "one or more claims" (Compl. ¶25).
U.S. Patent No. 11,141,405 - “Enalapril Formulations”
The Invention Explained
- Problem Addressed: As a continuation of the application leading to the ’023 Patent, this patent addresses the same technical problem of providing a stable, liquid oral dosage form of enalapril to improve administration and dosing accuracy for certain patient populations (’405 Patent, col. 5:31-61).
- The Patented Solution: The invention is a stable oral liquid formulation of enalapril defined by a specific set of required and optional components. The solution achieves stability, in part, by optionally using a buffer to maintain a pH of about 4.5 or below, which minimizes degradation of the active ingredient (’405 Patent, col. 2:32-38; col. 13:35-42).
- Technical Importance: This patented solution provides another route to a commercially stable, liquid dosage form of enalapril, broadening the formulation options available for pediatric and geriatric patient care (’405 Patent, col. 5:41-49).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶38).
- The essential elements of independent claim 1 are:
- A stable oral liquid formulation, consisting essentially of:
- (i) about 0.6 to about 1.2 mg/ml enalapril or a pharmaceutically acceptable salt or solvate thereof;
- (ii) a preservative selected from a specific list including sodium benzoate, parabens, and others; and
- (iii) water;
- wherein the formulation optionally comprises a buffer to maintain pH at about 4.5 or below, a sweetener, and a flavoring agent;
- wherein the formulation meets specific stability criteria for at least 12 months at 5±3° C, retaining at least 95% of the initial enalapril amount with 5% or less total impurity.
- The complaint does not explicitly reserve the right to assert dependent claims but refers to infringement of "one or more claims" (Compl. ¶52).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the "Novitium Formulation," identified as a generic version of Plaintiff's Epaned® product that is the subject of Bionpharma Inc.'s Abbreviated New Drug Application (ANDA) No. 212408 (Compl. ¶¶1, 9).
Functionality and Market Context
- The Novitium Formulation is a ready-to-use oral solution of enalapril maleate intended for the U.S. market (Compl. ¶¶1, 3). It is alleged to be the same formulation as one previously manufactured by CoreRx, Inc. and sold by Bionpharma Inc. (Compl. ¶9).
- The complaint alleges that Novitium has listed itself as the new manufacturer for Bionpharma's ANDA product and is poised to begin commercial manufacture, offer for sale, and sale of the formulation in the United States (Compl. ¶¶33, 34, 37).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not provide a claim chart or specific factual allegations mapping elements of the accused formulation to the patent claims. The infringement theory is based on a general allegation that the Novitium Formulation, as described in ANDA No. 212408, is covered by the asserted claims (Compl. ¶¶25, 38).
’023 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A stable oral liquid formulation, consisting essentially of: | The complaint alleges the Novitium Formulation is a stable oral liquid formulation that meets the claim limitations. | ¶38 | col. 26:42 |
| (i) about 0.6 to about 1.2 mg/ml enalapril or a pharmaceutically acceptable salt or solvate thereof; | The complaint alleges the Novitium Formulation is an oral solution of enalapril maleate. | ¶10 | col. 26:45-47 |
| (ii) a sweetener; | The complaint does not specify the sweetener but alleges the formulation infringes, which requires one. | ¶38 | col. 26:48 |
| (iii) a preservative, wherein the preservative comprises sodium benzoate, a paraben or a mixture of parabens; | The complaint does not specify the preservative but alleges the formulation infringes, which requires one from this group. | ¶38 | col. 26:49-51 |
| (iv) water; and (v) optionally a flavoring agent; | The complaint alleges the Novitium Formulation is an oral solution, implying the presence of water. | ¶10 | col. 26:52-54 |
| wherein the formulation is stable at about 5±3° C. for at least 12 months... [and meets specific impurity criteria] | The complaint alleges the Novitium Formulation is covered by the claim, which requires this stability profile. | ¶25 | col. 26:55-61 |
Identified Points of Contention
- Evidentiary Questions: The central issue will be whether the specific composition and performance data disclosed in ANDA No. 212408 for the Novitium Formulation meets every limitation of the asserted claim. The complaint itself provides no direct evidence on this point. Key questions will be:
- What are the precise concentrations of enalapril maleate and all excipients in the Novitium Formulation?
- What stability data was submitted in the ANDA, and does it demonstrate stability as defined in the claim (≥95% purity, ≤5% impurity after 12 months at 5±3° C)?
- Scope Questions: Claim 1 uses the transitional phrase "consisting essentially of." This raises the question of whether any unlisted excipients in the Novitium Formulation materially affect the "basic and novel properties" of the claimed invention, which appears to be its long-term stability at a low pH.
V. Key Claim Terms for Construction
The Term: "consisting essentially of" (’023 Patent, Claim 1; ’405 Patent, Claim 1)
- Context and Importance: This transitional phrase is critical for determining the scope of infringement. It permits the presence of unlisted ingredients so long as they do not materially alter the basic and novel characteristics of the invention. The core dispute may turn on whether any excipients in the Novitium Formulation, beyond those expressly recited, materially affect the claimed stability of the liquid enalapril formulation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patents' broad lists of potential excipients, such as sweeteners, preservatives, and buffers, may suggest that the "basic and novel properties" are not easily affected by common pharmaceutical additives, allowing for a wider range of unlisted ingredients (’023 Patent, col. 10:45-12:43).
- Evidence for a Narrower Interpretation: The patents emphasize that stability is highly sensitive to formulation parameters like pH and specific ingredients, noting that some preservatives (parabens) can react with certain sweeteners (sugar alcohols) (’023 Patent, col. 13:21-27). This suggests that the "basic and novel properties" are narrowly tied to the specific chemical environment that promotes stability, potentially limiting the scope of permissible unlisted ingredients.
The Term: "stable" (’023 Patent, Claim 1; ’405 Patent, Claim 1)
- Context and Importance: Both asserted claims explicitly define "stable" with a functional requirement: retaining ≥95% of the initial enalapril amount with ≤5% total impurity after 12 months at 5±3° C. The infringement analysis will depend entirely on whether the Novitium Formulation's performance characteristics meet this objective standard.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term is explicitly defined within the claim itself, which might limit the need for extensive construction beyond applying the plain language of the definition to the accused product's performance data. The specification further supports this definition by explaining how stability is assessed (’023 Patent, col. 17:51-18:8).
- Evidence for a Narrower Interpretation: The specification provides numerous examples of stability testing under various conditions (’023 Patent, Tables A-2, B-2, C-2, D-2). A defendant may argue that the methods and conditions used in those examples implicitly inform the meaning of "stable," potentially narrowing its application to formulations tested under highly similar protocols.
VI. Other Allegations
Indirect Infringement
- The complaint alleges inducement of infringement under 35 U.S.C. § 271(b) (Compl. ¶¶42, 53). The factual basis is the allegation that Novitium intends to manufacture and sell the Novitium Formulation to Bionpharma, knowing that Bionpharma will in turn sell the product for infringing uses in the United States. Knowledge of the patents and the alleged infringement is based on Novitium's awareness of the prior litigation against Bionpharma and CoreRx (Compl. ¶¶26, 28, 30).
Willful Infringement
- While not using the word "willful," the complaint alleges facts that may support such a claim. It asserts Novitium acted in "blatant disregard for Azurity's patent rights" (Compl. ¶33) and proceeded with its plans to manufacture the accused product "despite its knowledge of the '023 patent, the '023 Bionpharma Action, and the CoreRx Action" (Compl. ¶46).
VII. Analyst’s Conclusion: Key Questions for the Case
This case appears to be a standard Hatch-Waxman dispute framed as a declaratory judgment action, precipitated by a change in the generic manufacturer. The central questions for the court will likely be:
- A primary issue will be one of evidentiary proof: What do the chemistry, manufacturing, and controls (CMC) sections and stability data within ANDA No. 212408 reveal about the Novitium Formulation, and does this confidential information demonstrate that the formulation meets every positive and negative limitation of the asserted claims, including the specific stability requirements?
- A secondary issue will be one of claim scope: How should the phrase "consisting essentially of" be construed? The case may turn on whether any unlisted excipients present in the Novitium Formulation are found to "materially affect" the claimed formulation's basic and novel property of long-term stability at a controlled pH.